Unlike many cancers that cause pain, noticeable lumps, or other early symptoms, cervical cancer has no telltale warning signs until it is so advanced that it is usually unresponsive to treatment. Only in the late stages does cervical cancer cause pain in the lower abdominal or back region, or produce other noticeable symptoms. Tests which provide early detection of cervical, uterine and vaginal cancer are paramount to the effective treatment and recovery from the disease. A Papanicolaou smear test, commonly referred to as a “Pap test”, has long been established as a highly useful diagnostic tool that allows the identification of premalignant and malignant tissue at very early stages of the disease, as well as the identification of various inflammations and infections. The American Society of Clinical Pathologists recommends women have an annual Pap test.
A Pap test is a clinical procedure in which typically a bivalve speculum is inserted into a vaginal cavity and the cervix is exposed for sampling. A sample smear of cervical or vaginal secretions is then removed using an inserted scraper, probe, brush or similar type of device. The collected smear is evenly spread on one or more glass slides for microscopic examination. These standard-sized laboratory slides may be lined with hundreds of thousand of cervical cells. These slides are examined for the early detection of cancer or to determine the presence of certain hormonal conditions or certain infections. Lurking in these cells may be as few as a dozen abnormal cells. Finding such telltale cells is akin to finding a needle in a haystack, especially at the end of the day when laboratory technicians are likely to have examined countless Pap test slides. Therefore, the better the sampling and the better the cell preservation, the better the chance of detecting the presence of an abnormal cell. In addition, abnormalities in cell shape may be slight and difficult for even the trained eye to detect, or may be masked by infection.
At one time, Pap tests were performed almost exclusively by medical professionals in a doctor's office or a hospital. Many women, however, did not receive their yearly test because of their inability to visit a doctor on an annual basis, their reluctance to see a doctor or the expense of visiting a doctor coupled with test costs. As a result, self-administered, sample collecting kits or systems were developed so that women who did not go to the doctor on an annual basis could still be tested for abnormal cells. However, conventional self-administered sample collecting systems may not collect a sufficient amount of cervical tissue sample, or they may cause great discomfort to the user during use.
One such self-administered Pap test sampling collecting system is disclosed in U.S. Pat. No. 5,787,891 to Sak, that is herein incorporated by reference. This system includes a tubular speculum for inserting into the vaginal cavity, a guide sleeve located within the tubular speculum, and a swab assembly removably disposed within the guide sleeve. The swab assembly includes a sample collecting swab positioned within a swab sleeve in a retracted position when the device is first inserted into the vaginal cavity. A stem is then used for pushing the sample collecting swab out of the swab sleeve to an extended position and into contact with the cervical tissue. The sample collecting swab absorbs cervical samples until the user decides that enough sampling has been done.
Some patients may have difficulty using a self-administered sample collecting system because of the construction of its vaginal speculum. The speculum may be uncomfortable to insert into the vaginal cavity of the patient. The speculum may require the patient to use excessive force to push the speculum towards her cervix, thereby possibly causing an internal injury. Thus, the vaginal speculum may discourage women from taking the Pap test. Also, these self-administered sample collecting systems may not provide the user with the ability to determine the depth to which the vaginal speculum and the sampling device have been inserted into a vaginal cavity. The lack of proper insertion can lead to poor cervical samples and unreliable results.
Another problem that exists with conventional self-administered sample collecting systems for Pap tests is the inability of the patient to determine when enough of a sample has been obtained. Previous sampling systems do not effectively assist the patient in determining when the sampling device has been moved enough to obtain an adequate amount of sample. Improper sampling may give inaccurate test results, increase costs and discourage a woman from receiving testing at the recommended frequency.
A related problem exists with regard to the preparation and forwarding of a sample to a lab for analysis. As important as it is for the patient to collect a sufficient number of cells, it is also necessary that the maximum number of cells possible be sent to the lab. The more cells that can be properly preserved and transferred to the lab, the greater the chance that the lab can develop slides that will identify any cancerous or precancerous cells. Previous self-administered sample collecting systems have required the patient to place the collected sample on medical examination slides. This procedure can lead to an unsatisfactory specimen where bodily fluids can impede the diagnosis of the smear and prevent the atypical cells from being detected. This ineffective diagnosis can require the patient to repeat the procedure at a later time in order to obtain another sample.
To prevent patients from preparing slides and to provide labs with a large number of preserved cells from which to make slides, the sample collecting system disclosed in co-pending U.S. patent application Ser. No. 09/512,258 includes a sample collection container that carries a specific methanol-based thin layered preservative solution that is used as a transportation medium and in specimen preparation. This is at least in part because, as is known, conventional, ethanol alcohol-based cytofixatives typically used in slide preparation do not work effectively as transportation mediums and cell preservatives when provided in cell collection containers into which the sampling device is deposited for transporting to the lab. Therefore, the methanol-based preservative solutions have been used. Examples of the specifically developed solutions include CytoLyt® available from Cytyc® or a similar, specifically formulated thin layered preservative solution, such as Autocyte® PREP (or CytoRich®) available from Tri Path Imaging. However, these systems can be expensive to manufacture due to the high cost of the specific methanol-based thin layered preservative solutions that must be provided in the sample collection container. Additionally, the use of these special preservative solutions requires the lab that processes the sample to have expensive and state-of-the-art equipment. The cost of the sample systems and the state-of-the-art equipment needed to process and analyze the collected samples is so great that the use of these sample systems can be impractical in some parts of this country and certain poor sections of the world.
Thus, there is a need for an economical cervical sampling apparatus that can be effectively used by a woman performing sampling on herself. Further there is a need for an improved method of cervical sampling and an affordable, portable sampling system to advantageously provide for the detection of cancer.
It is an object of the present invention to overcome the aforementioned drawbacks in the conventional self-administered sample collecting systems for Pap tests.
An object of the present invention is to overcome the prior art problems of comfortably and effectively inserting a tubular speculum device in a vaginal cavity.
Another object of the present invention is to allow patients to readily determine when a sampling device has been rotated through a complete revolution so that the patient can keep an accurate count of how many times she has rotated the sample collecting device in order to achieve better sampling.
An additional object of the invention is to provide a sampling system that can provide useful, effectively preserved samples by using inexpensive, conventional ethanol alcohol-based fixatives.